Omeprazole - Santa Cruz Biotechnology, Inc.

Omeprazole
sc-202265
Material Safety Data Sheet
Hazard Alert Code
Key:
EXTREME
HIGH
MODERATE
LOW
Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
PRODUCT NAME
Omeprazole
STATEMENT OF HAZARDOUS NATURE
CONSIDERED A HAZARDOUS SUBSTANCE ACCORDING TO OSHA 29 CFR 1910.1200.
NFPA
1
FLAMMABILITY
2
HEALTH HAZARD
0
INSTABILITY
SUPPLIER
Santa Cruz Biotechnology, Inc.
2145 Delaware Avenue
Santa Cruz, California 95060
800.457.3801 or 831.457.3800
EMERGENCY
ChemWatch
Within the US & Canada: 877-715-9305
Outside the US & Canada: +800 2436 2255
(1-800-CHEMCALL) or call +613 9573 3112
SYNONYMS
C17-H19-N3-O3-S, "1H-benzimidazole, 5-methoxy-2-[((4-methoxy-3, 5-dimethyl-2-pyridinyl)-", methyl]sulfinyl-, "5-methoxy-2-[((4methoxy-3, 5-dimethyl-2-", pyridyl)methyl)sulfinyl]benzimidazole, Antra, Audazol, AULCER, Belmazol, Ceprandol, Elgam, Emeproton,
Gastrimut, Gastroloc, H-168/68, Indurgan, Losec, Miol, Mepral, Mopral, Omapren, Omepral, Omeprazole, Ompanyt, Parizac, Pepticum,
Prilosec, Prysma, Sanamidol, Secrepina, Ulceral, Ulcsep, Ulcometion, Zimor, "gastrointestinal agent/ gastric proton-pump inhibitor",
anti-ulcerative, Acimax
Section 2 - HAZARDS IDENTIFICATION
CHEMWATCH HAZARD RATINGS
Min
Flammability:
1
Toxicity:
2
Body Contact:
2
Reactivity:
1
Chronic:
2
Max
Min/Nil=0
Low=1
Moderate=2
High=3
Extreme=4
CANADIAN WHMIS SYMBOLS
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EMERGENCY OVERVIEW
RISK
May cause SENSITISATION by skin contact.
Irritating to eyes, respiratory system and skin.
Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
Ingestion may produce health damage*.
Cumulative effects may result following exposure*.
Limited evidence of a carcinogenic effect*.
Exposure may produce irreversible effects*.
* (limited evidence).
POTENTIAL HEALTH EFFECTS
ACUTE HEALTH EFFECTS
SWALLOWED
■ Accidental ingestion of the material may be damaging to the health of the individual.
■ Limited evidence exists that this substance may cause irreversible mutations (though not lethal) even following a single exposure.
■ Treatment with omeprazole is generally well tolerated. Side-effects may include headache, diarrhoea, abdominal pain, nausea, upper
airway infection symptoms, dizziness, vomiting, rash, constipation, cough, muscle weakness and back pain. Rare adverse effects
include fever, pain, fatigue, malaise, and abdominal swelling.
Other gastrointestinal effects include inflammation of the pancreas, anorexia, irritable bowel, flatulence, discoloured stools, thrush in the
gullet, shrinking of the tongue mucosa, dry mouth, benign growths in the stomach, and carcinoid of the stomach and duodenum. There
may be elevation of liver enzymes and obvious damage to the liver, even leading to liver-related brain disease. Blood sodium and sugar
may be low, and weight gain may occur; there may also be muscle cramps and pain, muscle weakness, joint and leg pain. Nervous
system effects may include depression, aggression, hallucinations, confusion, sleeplessness, nervousness, tremors, apathy, sleepiness,
anxiety, dream abnormalities, a spinning sensation, pins and needles and an unpleasant sensation on one side of the face. Nosebleeds
and pain in the pharynx may occur. There may be a skin rash, and very rarely, a severe, generalised skin reaction, skin inflammation,
hives, swelling, itch, hair loss, dry skin, excess sweating, toxic epidermal necrosis (which may cause death), Stevens-Johnson syndrome
and erythema multiforme. Ringing in the ears and taste perversion may occur. There may also be inflammation of the kidneys, urinary
tract infection, pus, protein, sugar and blood in the urine, more frequent urination, increased blood creatinine, pain in the testes and
enlarged breasts in the male. Reduced counts of platelets, neutrophils (sometimes fatal), red cells, white cells or all blood cells may
occur. Overdose may produce confusion, drowsiness, blurred vision, fast heart rate, nausea, sweating, flushing, headache and dry
mouth. Animal testing shows that before lethal poisoning there may be sedation, drooping of the eyelid, convulsions, decreased activity,
body temperature and rate of breathing, and deeper than usual breathing.
■ Gastric proton pump inhibitors (GPPIs) are generally well tolerated, and the incidence of short-term adverse effects is fairly
uncommon. Side effects are similar for all drugs in this group.
Common adverse effects include headache, nausea, diarrhoea, abdominal pain, fatigue and dizziness. Infrequently, there may be rash,
itch, flatulence and constipation. Long term use may reduce vitamin B12 absorption. Rarely, GPPIs may cause reactions such as
erythema multiforme, inflammation of the pancreas and kidney.
GPPIs reduce acid secretion from the stomach and this is related with an increased risk of developing community-acquired pneumonia.
Patients at high risk of pneumonia should only be given GPPIs at low doses, and only when necessary. GPPIs have also been shown to
increase the risk of infection with Clostridium difficile.
EYE
■ This material can cause eye irritation and damage in some persons.
SKIN
■ This material can cause inflammation of the skin oncontact in some persons.
■ The material may accentuate any pre-existing dermatitis condition.
■ Skin contact is not thought to have harmful health effects (as classified under EC Directives); the material may still produce health
damage following entry through wounds, lesions or abrasions.
■ Open cuts, abraded or irritated skin should not be exposed to this material.
■ Entry into the blood-stream, through, for example, cuts, abrasions or lesions, may produce systemic injury with harmful effects.
Examine the skin prior to the use of the material and ensure that any external damage is suitably protected.
INHALED
■ The material can cause respiratory irritation in some persons. The body's response to such irritation can cause further lung damage.
■ Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, may incur
further disability if excessive concentrations of particulate are inhaled.
If prior damage to the circulatory or nervous systems has occurred or if kidney damage has been sustained, proper screenings should
be conducted on individuals who may be exposed to further risk if handling and use of the material result
in excessive exposures.
■ Limited evidence exists that this substance may cause irreversible mutations (though not lethal) even following a single exposure.
CHRONIC HEALTH EFFECTS
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■ Long-term exposure to respiratory irritants may result in disease of the airways involving difficult breathing and related systemic
problems.
Skin contact with the material is more likely to cause a sensitisation reaction in some persons compared to the general population.
There has been some concern that this material can cause cancer or mutations but there is not enough data to make an assessment.
Substance accumulation, in the human body, may occur and may cause some concern following repeated or long-term occupational
exposure.
Based on laboratory and animal testing, exposure to the material may result in irreversible effects and mutations in humans.
Omeprazole is a skin strong sensitiser in animal assays.
Repeated oral doses of omeprazole in animals have produced adverse effects on kidney and the gastrointestinal tract. Short term tests
show that the material is unlikely to be a carcinogenic hazard in man.
In two 24-month carcinogenicity studies in rats, omeprazole (given at 4-352 times the human dosage) produced gastric ECL cell
carcinoids in a dose-related manner in both male and female rats ECL cell hyperplasia was present in all treatment groups. A 78-week
mouse carcinogenicity study did not show increased tumor occurrence.
Omeprazole was not mutagenic in an in vitro Ames Salmonella typhimurium assay, an in vitro mouse lymphoma cell assay and an in
vivo liver DNA damage assay. A mouse micronucleus test at 625 and 6250 times the human dose gave a borderline result, as did an in
vivo bone marrow chromosome aberration test.
In developmental studies with rabbits (at 17-172 times the human dose) the drug produced dose-related increases in embryo-lethality,
foetal resorptions, and pregnancy disruptions. In rats. dose-related embryo/foetal toxicity and post-natal developmental toxicity was seen
in offspring of parents treated with 13-138 times the human dose.
Sporadic reports have been received of congenital abnormalities occurring in infants born to woman receiving the drug during
pregnancy.
Human studies have shown that taking GPPIs long term can increase the risk of hip fracture, and the risk increases with the duration of
taking these drugs. These drugs have also been associated with induction of carcinoid-like tumours in the stomach; therefore, the use of
these drugs is generally restricted.
Benzimidazoles are shown to impair embryonic development and cause genetic abnormalities (often errors in the number of
chromosomes). Their activity in the body may also cause cancer and genetic defects by interfering with nucleic acids function.
Section 3 - COMPOSITION / INFORMATION ON INGREDIENTS
NAME
CAS RN
%
omeprazole
73590-58-6
>98
Section 4 - FIRST AID MEASURES
SWALLOWED
If swallowed do NOT induce vomiting.
If vomiting occurs, lean patient forward or place on left side (head-down position, if possible) to maintain open airway and prevent
aspiration.
Observe the patient carefully.
Never give liquid to a person showing signs of being sleepy or with reduced awareness; i.e. becoming unconscious.
Give water to rinse out mouth, then provide liquid slowly and as much as casualty can comfortably drink.
Seek medical advice.
EYE
If this product comes in contact with the eyes:
Wash out immediately with fresh running water.
Ensure complete irrigation of the eye by keeping eyelids apart and away from eye and moving the eyelids by occasionally lifting the
upper and lower lids.
Seek medical attention without delay; if pain persists or recurs seek medical attention.
Removal of contact lenses after an eye injury should only be undertaken by skilled personnel.
SKIN
If skin contact occurs:
Immediately remove all contaminated clothing, including footwear.
Flush skin and hair with running water (and soap if available).
Seek medical attention in event of irritation.
INHALED
If fumes or combustion products are inhaled remove from contaminated area.
Lay patient down. Keep warm and rested.
Prostheses such as false teeth, which may block airway, should be removed, where possible, prior to initiating first aid procedures.
Apply artificial respiration if not breathing, preferably with a demand valve resuscitator, bag-valve mask device, or pocket mask as
trained. Perform CPR if necessary.
Transport to hospital, or doctor, without delay.
NOTES TO PHYSICIAN
■ Treat symptomatically.
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No antidote is known. Omeprazole is extensively protein-bound and is therefore not readily dialysable.
Section 5 - FIRE FIGHTING MEASURES
Vapour Pressure (mmHG):
Negligible
Upper Explosive Limit (%):
Not available.
Specific Gravity (water=1):
Not available
Lower Explosive Limit (%):
Not available
EXTINGUISHING MEDIA
Foam.
Dry chemical powder.
BCF (where regulations permit).
Carbon dioxide.
Water spray or fog - Large fires only.
FIRE FIGHTING
Alert Fire Brigade and tell them location and nature of hazard.
Wear breathing apparatus plus protective gloves.
Prevent, by any means available, spillage from entering drains or water courses.
Use water delivered as a fine spray to control fire and cool adjacent area.
DO NOT approach containers suspected to be hot.
Cool fire exposed containers with water spray from a protected location.
If safe to do so, remove containers from path of fire.
Equipment should be thoroughly decontaminated after use.
GENERAL FIRE HAZARDS/HAZARDOUS COMBUSTIBLE PRODUCTS
Combustible solid which burns but propagates flame with difficulty; it is estimated that most organic dusts are combustible (circa
70%) - according to the circumstances under which the combustion process occurs, such materials may cause fires and / or dust
explosions.
Organic powders when finely divided over a range of concentrations regardless of particulate size or shape and suspended in air or
some other oxidizing medium may form explosive dust-air mixtures and result in a fire or dust explosion (including secondary
explosions).
Avoid generating dust, particularly clouds of dust in a confined or unventilated space as dusts may form an explosive mixture with air,
and any source of ignition, i.e. flame or spark, will cause fire or explosion. Dust clouds generated by the fine grinding of the solid are
a particular hazard; accumulations of fine dust (420 micron or less) may burn rapidly and fiercely if ignited - particles exceeding this
limit will generally not form flammable dust clouds.; once initiated, however, larger particles up to 1400 microns diameter will
contribute to the propagation of an explosion.
In the same way as gases and vapours, dusts in the form of a cloud are only ignitable over a range of concentrations; in principle,
the concepts of lower explosive limit (LEL) and upper explosive limit (UEL).are applicable to dust clouds but only the LEL is of
practical use; - this is because of the inherent difficulty of achieving homogeneous dust clouds at high temperatures (for dusts the
LEL is often called the "Minimum Explosible Concentration", MEC)
When processed with flammable liquids/vapors/mists,ignitable (hybrid) mixtures may be formed with combustible dusts. Ignitable
mixtures will increase the rate of explosion pressure rise and the Minimum Ignition Energy (the minimum amount of energy required
to ignite dust clouds - MIE) will be lower than the pure dust in air mixture. The Lower Explosive Limit (LEL) of the vapour/dust mixture
will be lower than the individual LELs for the vapors/mists or dusts
A dust explosion may release of large quantities of gaseous products; this in turn creates a subsequent pressure rise of explosive
force capable of damaging plant and buildings and injuring people.
Usually the initial or primary explosion takes place in a confined space such as plant or machinery, and can be of sufficient force to
damage or rupture the plant. If the shock wave from the primary explosion enters the surrounding area, it will disturb any settled dust
layers, forming a second dust cloud, and often initiate a much larger secondary explosion. All large scale explosions have resulted
from chain reactions of this type.
Dry dust can be charged electrostatically by turbulence, pneumatic transport, pouring, in exhaust ducts and during transport.
Build-up of electrostatic charge may be prevented by bonding and grounding.
Powder handling equipment such as dust collectors, dryers and mills may require additional protection measures such as explosion
venting.
All movable parts coming in contact with this material should have a speed of less than 1-meter/sec
A sudden release of statically charged materials from storage or process equipment, particularly at elevated temperatures and/ or
pressure, may result in ignition especially in the absence of an apparent ignition source
One important effect of the particulate nature of powders is that the surface area and surface structure (and often moisture content)
can vary widely from sample to sample, depending of how the powder was manufactured and handled; this means that it is virtually
impossible to use flammability data published in the literature for dusts (in contrast to that published for gases and vapours).
Autoignition temperatures are often quoted for dust clouds (minimum ignition temperature (MIT)) and dust layers (layer ignition
temperature (LIT)); LIT generally falls as the thickness of the layer increases.
Combustion products include: carbon monoxide (CO), carbon dioxide (CO2), nitrogen oxides (NOx), sulfur oxides (SOx), other pyrolysis
products typical of burning organic material.
May emit poisonous fumes.
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May emit corrosive fumes.
FIRE INCOMPATIBILITY
Avoid contamination with oxidising agents i.e. nitrates, oxidising acids, chlorine bleaches, pool chlorine etc. as ignition may result
Section 6 - ACCIDENTAL RELEASE MEASURES
MINOR SPILLS
Clean up waste regularly and abnormal spills immediately.
Avoid breathing dust and contact with skin and eyes.
Wear protective clothing, gloves, safety glasses and dust respirator.
Use dry clean up procedures and avoid generating dust.
Vacuum up or sweep up. NOTE: Vacuum cleaner must be fitted with an exhaust micro filter (HEPA type) (consider explosion-proof
machines designed to be grounded during storage and use).
Dampen with water to prevent dusting before sweeping.
Place in suitable containers for disposal.
MAJOR SPILLS
Moderate hazard.
CAUTION: Advise personnel in area.
Alert Emergency Services and tell them location and nature of hazard.
Control personal contact by wearing protective clothing.
Prevent, by any means available, spillage from entering drains or water courses.
Recover product wherever possible.
IF DRY: Use dry clean up procedures and avoid generating dust. Collect residues and place in sealed plastic bags or other
containers for disposal. IF WET: Vacuum/shovel up and place in labelled containers for disposal.
ALWAYS: Wash area down with large amounts of water and prevent runoff into drains.
If contamination of drains or waterways occurs, advise Emergency Services.
Section 7 - HANDLING AND STORAGE
PROCEDURE FOR HANDLING
Avoid all personal contact, including inhalation.
Wear protective clothing when risk of exposure occurs.
Use in a well-ventilated area.
Prevent concentration in hollows and sumps.
DO NOT enter confined spaces until atmosphere has been checked.
DO NOT allow material to contact humans, exposed food or food utensils.
Avoid contact with incompatible materials.
When handling, DO NOT eat, drink or smoke.
Keep containers securely sealed when not in use.
Avoid physical damage to containers.
Always wash hands with soap and water after handling.
Work clothes should be laundered separately. Launder contaminated clothing before re-use.
Use good occupational work practice.
Observe manufacturer's storing and handling recommendations.
Atmosphere should be regularly checked against established exposure standards to ensure safe working conditions are maintained.
Organic powders when finely divided over a range of concentrations regardless of particulate size or shape and suspended in air or
some other oxidizing medium may form explosive dust-air mixtures and result in a fire or dust explosion (including secondary
explosions)
Minimise airborne dust and eliminate all ignition sources. Keep away from heat, hot surfaces, sparks, and flame.
Establish good housekeeping practices.
Remove dust accumulations on a regular basis by vacuuming or gentle sweeping to avoid creating dust clouds.
Use continuous suction at points of dust generation to capture and minimise the accumulation of dusts. Particular attention should be
given to overhead and hidden horizontal surfaces to minimise the probability of a "secondary" explosion. According to NFPA
Standard 654, dust layers 1/32 in.(0.8 mm) thick can be sufficient to warrant immediate cleaning of the area.
Do not use air hoses for cleaning.
Minimise dry sweeping to avoid generation of dust clouds. Vacuum dust-accumulating surfaces and remove to a chemical disposal
area. Vacuums with explosion-proof motors should be used.
Control sources of static electricity. Dusts or their packages may accumulate static charges, and static discharge can be a source of
ignition.
Solids handling systems must be designed in accordance with applicable standards (e.g. NFPA including 654 and 77) and other
national guidance.
Do not empty directly into flammable solvents or in the presence of flammable vapors.
The operator, the packaging container and all equipment must be grounded with electrical bonding and grounding systems. Plastic
bags and plastics cannot be grounded, and antistatic bags do not completely protect against development of static charges.
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Empty containers may contain residual dust which has the potential to accumulate following settling. Such dusts may explode in the
presence of an appropriate ignition source.
Do NOT cut, drill, grind or weld such containers.
In addition ensure such activity is not performed near full, partially empty or empty containers without appropriate workplace safety
authorisation or permit.
RECOMMENDED STORAGE METHODS
Glass container is suitable for laboratory quantities
Polyethylene or polypropylene container.
Check all containers are clearly labelled and free from leaks.
STORAGE REQUIREMENTS
Store in original containers.
Keep containers securely sealed.
Store in a cool, dry area protected from environmental extremes.
Store away from incompatible materials and foodstuff containers.
Protect containers against physical damage and check regularly for leaks.
Observe manufacturer's storing and handling recommendations
For major quantities:
Consider storage in bunded areas - ensure storage areas are isolated from sources of community water (including stormwater,
ground water, lakes and streams}.
Ensure that accidental discharge to air or water is the subject of a contingency disaster management plan; this may require
consultation with local authorities.
Store at 4 ºC.
Section 8 - EXPOSURE CONTROLS / PERSONAL PROTECTION
EXPOSURE CONTROLS
The following materials had no OELs on our records
omeprazole: CAS:73590-58-6
PERSONAL PROTECTION
RESPIRATOR
Particulate. (AS/NZS 1716 & 1715, EN 143:2000 & 149:2001, ANSI Z88 or national equivalent)
EYE
When handling very small quantities of the material eye protection may not be required.
For laboratory, larger scale or bulk handling or where regular exposure in an occupational setting occurs:
Chemical goggles
Face shield. Full face shield may be required for supplementary but never for primary protection of eyes
Contact lenses may pose a special hazard; soft contact lenses may absorb and concentrate irritants. A written policy document,
describing the wearing of lens or restrictions on use, should be created for each workplace or task. This should include a review of
lens absorption and adsorption for the class of chemicals in use and an account of injury experience. Medical and first-aid personnel
should be trained in their removal and suitable equipment should be readily available. In the event of chemical exposure, begin eye
irrigation immediately and remove contact lens as soon as practicable. Lens should be removed at the first signs of eye redness or
irritation - lens should be removed in a clean environment only after workers have washed hands thoroughly. [CDC NIOSH Current
Intelligence Bulletin 59], [AS/NZS 1336 or national equivalent]
HANDS/FEET
NOTE:
The material may produce skin sensitisation in predisposed individuals. Care must be taken, when removing gloves and other
protective equipment, to avoid all possible skin contact.
Contaminated leather items, such as shoes, belts and watch-bands should be removed and destroyed.
Suitability and durability of glove type is dependent on usage. Important factors in the selection of gloves include:
frequency and duration of contact,
chemical resistance of glove material,
glove thickness and
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dexterity
Select gloves tested to a relevant standard (e.g. Europe EN 374, US F739, AS/NZS 2161.1 or national equivalent).
When prolonged or frequently repeated contact may occur, a glove with a protection class of 5 or higher (breakthrough time greater
than 240 minutes according to EN 374, AS/NZS 2161.10.1 or national equivalent) is recommended.
When only brief contact is expected, a glove with a protection class of 3 or higher (breakthrough time greater than 60 minutes
according to EN 374, AS/NZS 2161.10.1 or national equivalent) is recommended.
Contaminated gloves should be replaced.
Gloves must only be worn on clean hands. After using gloves, hands should be washed and dried thoroughly. Application of a
non-perfumed moisturiser is recommended.
Rubber gloves (nitrile or low-protein, powder-free latex, latex/ nitrile). Employees allergic to latex gloves should use nitrile gloves in
preference.
Double gloving should be considered.
PVC gloves.
Change gloves frequently and when contaminated, punctured or torn.
Wash hands immediately after removing gloves.
Protective shoe covers. [AS/NZS 2210]
Head covering.
Experience indicates that the following polymers are suitable as glove materials for protection against undissolved, dry solids, where
abrasive particles are not present.
polychloroprene
nitrile rubber
butyl rubber
fluorocaoutchouc
polyvinyl chloride
Gloves should be examined for wear and/ or degradation constantly.
OTHER
For quantities up to 500 grams a laboratory coat may be suitable.
For quantities up to 1 kilogram a disposable laboratory coat or coverall of low permeability is recommended. Coveralls should be
buttoned at collar and cuffs.
For quantities over 1 kilogram and manufacturing operations, wear disposable coverall of low permeability and disposable shoe
covers.
For manufacturing operations, air-supplied full body suits may be required for the provision of advanced respiratory protection.
Eye wash unit.
Ensure there is ready access to an emergency shower.
For Emergencies: Vinyl suit
ENGINEERING CONTROLS
■ Enclosed local exhaust ventilation is required at points of dust, fume or vapour generation.
HEPA terminated local exhaust ventilation should be considered at point of generation of dust, fumes or vapours.
Barrier protection or laminar flow cabinets should be considered for laboratory scale handling.
When handling quantities up to 500 gram in either a standard laboratory with general dilution ventilation (e.g. 6-12 air changes per hour)
is preferred. Quantities up to 1 kilogram may require a designated laboratory using fume hood, biological safety cabinet, or approved
vented enclosures. Quantities exceeding 1 kilogram should be handled in a designated laboratory or containment laboratory using
appropriate barrier/ containment technology.
Manufacturing and pilot plant operations require barrier/ containment and direct coupling technologies.
Barrier/ containment technology and direct coupling (totally enclosed processes that create a barrier between the equipment and the
room) typically use double or split butterfly valves and hybrid unidirectional airflow/ local exhaust ventilation solutions (e.g. powder
containment booths). Glove bags, isolator glove box systems are optional. HEPA filtration of exhaust from dry product handling areas is
required.
Fume-hoods and other open-face containment devices are acceptable when face velocities of at least 1 m/s (200 feet/minute) are
achieved. Partitions, barriers, and other partial containment technologies are required to prevent migration of the material to uncontrolled
areas. For non-routine emergencies maximum local and general exhaust are necessary. Air contaminants generated in the workplace
possess varying "escape" velocities which, in turn, determine the "capture velocities" of fresh circulating air required to effectively
remove the contaminant.
Type of Contaminant:
solvent, vapours, etc. evaporating from tank (in still air)
aerosols, fumes from pouring operations, intermittent
container filling, low speed conveyer transfers (released
at low velocity into zone of active generation)
direct spray, drum filling, conveyer loading, crusher
dusts, gas discharge (active generation into zone of
rapid air motion)
Air Speed:
0.25-0.5 m/s (50-100 f/min.)
0.5-1 m/s (100-200 f/min.)
1-2.5 m/s (200-500 f/min.)
Within each range the appropriate value depends on:
Lower end of the range
1: Room air currents minimal or favourable to capture
Upper end of the range
1: Disturbing room air currents
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2: Contaminants of low toxicity or of nuisance value
only.
3: Intermittent, low production.
4: Large hood or large air mass in motion
2: Contaminants of high toxicity
3: High production, heavy use
4: Small hood-local control only
Simple theory shows that air velocity falls rapidly with distance away from the opening of a simple extraction pipe. Velocity generally
decreases with the square of distance from the extraction point (in simple cases). Therefore the air speed at the extraction point should
be adjusted, accordingly, after reference to distance from the contaminating source. The air velocity at the extraction fan, for example,
should be a minimum of 1-2.5 m/s (200-500 f/min.) for extraction of gases discharged 2 meters distant from the extraction point. Other
mechanical considerations, producing performance deficits within the extraction apparatus, make it essential that theoretical air
velocities are multiplied by factors of 10 or more when extraction systems are installed or used.
The need for respiratory protection should also be assessed where incidental or accidental exposure is anticipated: Dependent on levels
of contamination, PAPR, full face air purifying devices with P2 or P3 filters or air supplied respirators should be evaluated.
The following protective devices are recommended where exposures exceed the recommended exposure control guidelines by factors
of:
10; high efficiency particulate (HEPA) filters or cartridges
10-25; loose-fitting (Tyvek or helmet type) HEPA powered-air purifying respirator.
25-50; a full face-piece negative pressure respirator with HEPA filters
50-100; tight-fitting, full face-piece HEPA PAPR
100-1000; a hood-shroud HEPA PAPR or full face-piece supplied air respirator operated in pressure demand or other positive pressure
mode.
Section 9 - PHYSICAL AND CHEMICAL PROPERTIES
PHYSICAL PROPERTIES
Solid.
Does not mix with water.
State
Divided solid
Molecular Weight
345.4
Melting Range (°F)
313
Viscosity
Not Applicable
Boiling Range (°F)
Not available
Solubility in water (g/L)
Partly miscible
Flash Point (°F)
Not available
pH (1% solution)
Not applicable
Decomposition Temp (°F)
Not available.
pH (as supplied)
Not applicable
Autoignition Temp (°F)
Not available
Vapour Pressure (mmHG)
Negligible
Upper Explosive Limit (%)
Not available.
Specific Gravity (water=1)
Not available
Lower Explosive Limit (%)
Not available
Relative Vapour Density (air=1)
>1
Volatile Component (%vol)
Negligible
Evaporation Rate
Not applicable
APPEARANCE
Crystalline powder; does not mix well with water. Soluble in ethanol, methanol. A weak base, rapidly degraded in acid media.
Section 10 - CHEMICAL STABILITY
CONDITIONS CONTRIBUTING TO INSTABILITY
Presence of incompatible materials.
Product is considered stable.
Hazardous polymerisation will not occur.
STORAGE INCOMPATIBILITY
Avoid reaction with oxidising agents
For incompatible materials - refer to Section 7 - Handling and Storage.
Section 11 - TOXICOLOGICAL INFORMATION
omeprazole
TOXICITY AND IRRITATION
OMEPRAZOLE:
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■ unless otherwise specified data extracted from RTECS - Register of Toxic Effects of Chemical Substances.
TOXICITY
IRRITATION
Oral (rat) LD50: 2210 mg/kg
Nil Reported
Intraperitoneal (rat) LD50: >100 mg/kg
Subcutaneous (rat) LD50: >100 mg/kg
Intravenous (rat) LD50: >50 mg/kg
Oral (mouse) LD50: >4000 mg/kg
Intraperitoneal (mouse) LD50: >100 mg/kg
Subcutaneous (mouse) LD50: >100 mg/kg
Intravenous (mouse) LD50: 82.8 mg/kg
■ Contact allergies quickly manifest themselves as contact eczema, more rarely as urticaria or Quincke's oedema. The pathogenesis of
contact eczema involves a cell-mediated (T lymphocytes) immune reaction of the delayed type. Other allergic skin reactions, e.g. contact
urticaria, involve antibody-mediated immune reactions. The significance of the contact allergen is not simply determined by its
sensitisation potential: the distribution of the substance and the opportunities for contact with it are equally important. A weakly
sensitising substance which is widely distributed can be a more important allergen than one with stronger sensitising potential with which
few individuals come into contact. From a clinical point of view, substances are noteworthy if they produce an allergic test reaction in
more than 1% of the persons tested.
Asthma-like symptoms may continue for months or even years after exposure to the material ceases. This may be due to a
non-allergenic condition known as reactive airways dysfunction syndrome (RADS) which can occur following exposure to high levels of
highly irritating compound. Key criteria for the diagnosis of RADS include the absence of preceding respiratory disease, in a non-atopic
individual, with abrupt onset of persistent asthma-like symptoms within minutes to hours of a documented exposure to the irritant. A
reversible airflow pattern, on spirometry, with the presence of moderate to severe bronchial hyperreactivity on methacholine challenge
testing and the lack of minimal lymphocytic inflammation, without eosinophilia, have also been included in the criteria for diagnosis of
RADS. RADS (or asthma) following an irritating inhalation is an infrequent disorder with rates related to the concentration of and
duration of exposure to the irritating substance. Industrial bronchitis, on the other hand, is a disorder that occurs as result of exposure
due to high concentrations of irritating substance (often particulate in nature) and is completely reversible after exposure ceases. The
disorder is characterised by dyspnea, cough and mucus production.
NOTE: Substance has been shown to be mutagenic in at least one assay, or belongs to a family of chemicals producing damage or
change to cellular DNA.
Recordings from specific areas of the CNS, hepatitis, jaundice, changes in
urine composition, changes in kidney tubules, normocytic anaemia, body
temperature increase, pleural effusion, cough, urticaria, allergic
rhinitis, serum sickness, eosinophilia, interstitial nephritis, dermatitis
after systemic exposure, joint abnormalities, effects on inflammation,
ptosis, changes in motor activity, respiratory depression, diarrhoea,
dyspnea, convulsions, ataxia, body temperature decrease, maternal effects
recorded.
Section 12 - ECOLOGICAL INFORMATION
Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
Ecotoxicity
Ingredient
Persistence:
Water/Soil
Persistence: Air
Bioaccumulation
Mobility
omeprazole
HIGH
No Data Available
LOW
LOW
Section 13 - DISPOSAL CONSIDERATIONS
Disposal Instructions
All waste must be handled in accordance with local, state and federal regulations.
Containers may still present a chemical hazard/ danger when empty.
Return to supplier for reuse/ recycling if possible.
Otherwise:
If container can not be cleaned sufficiently well to ensure that residuals do not remain or if the container cannot be used to store the
same product, then puncture containers, to prevent re-use, and bury at an authorised landfill.
Where possible retain label warnings and MSDS and observe all notices pertaining to the product.
Legislation addressing waste disposal requirements may differ by country, state and/ or territory. Each user must refer to laws operating
in their area. In some areas, certain wastes must be tracked.
A Hierarchy of Controls seems to be common - the user should investigate:
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Reduction
Reuse
Recycling
Disposal (if all else fails)
This material may be recycled if unused, or if it has not been contaminated so as to make it unsuitable for its intended use. Shelf life
considerations should also be applied in making decisions of this type. Note that properties of a material may change in use, and
recycling or reuse may not always be appropriate. In most instances the supplier of the material should be consulted.
DO NOT allow wash water from cleaning or process equipment to enter drains.
It may be necessary to collect all wash water for treatment before disposal.
In all cases disposal to sewer may be subject to local laws and regulations and these should be considered first.
Where in doubt contact the responsible authority.
Recycle wherever possible.
Consult manufacturer for recycling options or consult local or regional waste management authority for disposal if no suitable
treatment or disposal facility can be identified.
Dispose of by: burial in a land-fill specifically licenced to accept chemical and / or pharmaceutical wastes or Incineration in a licenced
apparatus (after admixture with suitable combustible material)
Decontaminate empty containers. Observe all label safeguards until containers are cleaned and destroyed.
Section 14 - TRANSPORTATION INFORMATION
NOT REGULATED FOR TRANSPORT OF DANGEROUS GOODS: DOT, IATA, IMDG
Section 15 - REGULATORY INFORMATION
omeprazole (CAS: 73590-58-6) is found on the following regulatory lists;
"Canada Substances in Products Regulated Under the Food and Drugs Act (F&DA) That Were In Commerce between January 1, 1987
and September 13, 2001 (English)", "US FDA Maximum Recommended Therapeutic Dose (MRTD) Database"
Section 16 - OTHER INFORMATION
LIMITED EVIDENCE
■ Ingestion may produce health damage*.
■ Cumulative effects may result following exposure*.
■ Limited evidence of a carcinogenic effect*.
■ Exposure may produce irreversible effects*.
* (limited evidence).
■ Classification of the preparation and its individual components has drawn on official and authoritative sources as well as independent
review by the Chemwatch Classification committee using available literature references.
A list of reference resources used to assist the committee may be found at:
www.chemwatch.net/references.
■ The (M)SDS is a Hazard Communication tool and should be used to assist in the Risk Assessment. Many factors determine whether
the reported Hazards are Risks in the workplace or other settings. Risks may be determined by reference to Exposures Scenarios.
Scale of use, frequency of use and current or available engineering controls must be considered.
■ For detailed advice on Personal Protective Equipment, refer to the following U.S. Regulations and Standards:
OSHA Standards - 29 CFR:
1910.132 - Personal Protective Equipment - General requirements
1910.133 - Eye and face protection
1910.134 - Respiratory Protection
1910.136 - Occupational foot protection
1910.138 - Hand Protection
Eye and face protection - ANSI Z87.1
Foot protection - ANSI Z41
Respirators must be NIOSH approved.
This document is copyright. Apart from any fair dealing for the purposes of private study, research, review or
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criticism, as permitted under the Copyright Act, no part may be reproduced by any process without written
permission from CHEMWATCH. TEL (+61 3) 9572 4700.
www.Chemwatch.net
Issue Date: Jul-30-2010
Print Date:Apr-6-2012
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